Suspended

Treatment of Essential Hypertension With Vasodip-Combo 20. Efficacy and Safety Evaluation With 24 h Ambulatory Blood Pressure Measurements

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What is being tested

Lercanidipine/enalapril fixed combination

Drug
Who is being recruted

Cardiovascular Diseases

+ Hypertension

+ Vascular Diseases

From 18 to 80 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2011
See protocol details

Summary

Principal SponsorMeir Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2011

Actual date on which the first participant was enrolled.

This is a single centre observational uncontrolled prospective study, Hypertensive patients that are either treatment naïve or uncontrolled on current therapy \[one or two drugs\] and meet all inclusion and exclusion criteria, will be assigned to Vasodip-Combo 20 as unique drug treatment. The treatment will then be continued for additional 4 weeks. Office blood pressure will be performed by the physician at each visit. 24 h. ambulatory blood pressure measurements \[ABPM\] and blood samples for electrolytes, creatinine and urea will be taken at base line visit and at at week 4. Efficacy will be defined in terms of therapeutic goals expressed as target blood pressures according to World Health Organization and European society of Hypertension \[ for office blood pressure and ambulatory blood pressure measurements\] criteria: Office Blood Pressure: Diastolic blood pressure ≤ 90 mmHg and Systolic blood pressure ≤ 140 mmHg for non-diabetics or Diastolic Blood Pressure ≤ 80 mmHg and Systolic Blood Pressure ≤ 130 mmHg for diabetics, respectively. 24 h Ambulatory Blood Pressure Measurements: 224 Hour: Diastolic Blood Pressure≤ 80 mmHg and Systolic Blood Pressure ≤ 130 mmHg, Awake time: Diastolic Blood Pressure ≤ 85 mmHg,Systolic Blood Pressure ≤ 135 mmHg Asleep Time: Diastolic Blood Pressure ≤70 mmHg, Systolic Blood Pressure ≤ 70 mmHg. Effectiveness and Safety will also be evaluated taking into consideration patient compliance Safety assessments: Safety will be assessed by means of (S)Adverse effects reporting.

Official TitleTreatment of Essential Hypertension With Vasodip-Combo 20. Efficacy and Safety Evaluation With 24 h Ambulatory Blood Pressure Measurements
Principal SponsorMeir Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHypertensionVascular Diseases

Criteria

5 inclusion criteria required to participate
Essential hypertension at visit 1 defined as office blood pressure <140/90 mmHg and a 24 h ABPM >130/80 mmHg with a day time blood pressure (extracted from the 24h ABPM) >135/85 mmHg

Male and female

Age 18-80

Every patient that in the medical opinion of the treating physician is eligible for Vasodip Combo 20 treatment.

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11 exclusion criteria prevent from participating
Use of more than 2 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)

Mean 24 h ABPM values of more than 180/100 mmHg

Pregnant women

Women with potential age of pregnancy.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
uncontrolled hypertensive patients will receive fixed combination therapy

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Clalit Health Services

Herzliya, IsraelOpen Clalit Health Services in Google Maps
SuspendedOne Study Center